Evaluating FDA's Proposed Patient Medication Information Handout

NCT06320808 | Completed

• 1 other identifier: STUDY2023_00000449
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to assess how useful the proposed one-page FDA-template PMI is to potential users. The main questions it aims to answer are: How does the proposed one-page FDA-template PMI compare with the current drug information insert in terms of usefulness and comprehension? and How does the proposed one-page FDA-template PMI compare with a revision adding drug benefit information? Participants will randomized to review one of three patient medication information sheets and then asked questions related to usefulness and comprehension.

Conditions

Knowledge; Attitude

Outcome Measures

Primary Outcomes (4)

• Perceived difficulty or ease in reading information

  Single question with a 5-point likert scale response for "How easy or difficult was it to read the medication information guide about \[drug\]?" Minimum score is 1; Maximum score is 5. A higher score represents higher perceived usefulness.

  day 1

• Perceived usefulness of the medication information guide in making a use decision

  Single question with a 5-point likert scale response for "For someone who had not yet decided to use \[drug\], how useful would the medication information guide be in helping them to make that decision?" Minimum score is 1. Maximum score is 5. A higher score represents higher perceived usefulness.

  day 1

• Perceived usefulness of the medication information guide in taking the medication properly

  Single question with a 5-point likert scale response for "If someone had decided to use \[drug\], how useful would the medication information guide about \[drug\] be in helping them use the drug properly? " Minimum score is 1. Maximum score is 5. A higher score represents higher perceived usefulness.

  day 1

• Comprehension

  10 newly-constructed questions designed to measure the comprehension of the following information from the medication information guide: 1) Analysis of condition (1 question) 2) Risks (3 questions) 3)Risk Management (3 questions), and 5) Benefits (3 questions). Participants can score from 0-10 with 10 representing full comprehension of the information and 0 representing no comprehension of the information.

  day 1

Secondary Outcomes (1)

• Strength of Evidence

  day 1

Study Arms (3)

FDA-template PMI

EXPERIMENTAL

Patient medication information designed according to FDA template

Other: FDA template PMI

Decision Critical PMI

EXPERIMENTAL

Patient medication information designed according to FDA template and modified, according to decision science principles, to include benefit information

Other: Decision Critical PMI

Standard Information

EXPERIMENTAL

Standard of care patient medication information

Other: Standard Information

Interventions

FDA template PMI OTHER

Intervention is an information format viewed by participants. The patient medication information format was designed according to a proposed FDA template, which provides information about safe and effective use of a medication. No drug or device is included as part of this intervention.

FDA-template PMI

Decision Critical PMI OTHER

Intervention is an information format viewed by participants. The patient medication information format was designed according to a proposed FDA template and modified, according to decision science principles, to include benefit information, which provides information about safe and effective use of a medication. No drug or device is included as part of this intervention.

Decision Critical PMI

Standard Information OTHER

The intervention is an information format viewed by participants. This patient medication information format is the current standard of care patient medication information that is included with the drug. No drug or device is included as part of this intervention.

Standard Information

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Limited to females of reproductive age
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• US geographic location
• years of age
• assigned female sex at birth

You may not qualify if:

• \<18 years of age
• \> 45 years of age
• assigned a sex other than female at birth

Sponsors & Collaborators

• Carnegie Mellon University: lead
• University of Pittsburgh: collaborator

Study Sites (1)

Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Professor

Model Details: Participants will be randomized to receive either the one-page FDA-template PMI (FDA PMI), a modified template, which added information about drug benefits (Decision Critical PMI), or the existing drug information insert (standard drug information). Participants will complete the same survey questions measuring perceived usefulness and comprehension of the information.

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 20, 2024
• Study Start: March 3, 2024
• Primary Completion: March 4, 2024
• Study Completion: February 6, 2025
• Last Updated: November 10, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)